Caramel color concerns prompt change

April 10, 2012
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by Jeff Gelski

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Caramel color suppliers are promoting the safety of their ingredients while simultaneously striving to meet customer requests for certain classes of caramel color that contain less of a byproduct, 4-methylimidazole (4-MeI). As a result, color suppliers are developing alternatives to address customer concerns.

The customers may face labeling concerns in California since the Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency added 4-MeI to its list of chemicals known to the state to cause cancer and fall under the auspices of the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

The California determination comes even though last year Health Canada determined low levels of 4-MeI that may be found in food, including certain caramel colors, do not represent a risk to consumers. The European Food Safety Authority established a group acceptable daily intake (A.D.I.) of 300 mg per kilogram (2.2 lbs) of body weight per day for caramel colors while one caramel color (E150c) had an A.D.I. of 100 mg per kilogram of body weight per day.

“For generations caramel colors have been safely manufactured and used throughout the world, and it is the most widely used food colorant,” he said. “GRAS status would not be available for caramel color without sound evidence. There have been numerous studies showing the safety of its use in food and beverages.”

The California ruling is based on research associated with the National Toxicology Program that involved feeding diets containing 4-MeI to 50 male rats, 50 female rats, 50 male mice and 50 female mice over two years. Research found equivocal evidence of carcinogenic activity of 4-MeI in female rats based on increased evidence of mononuclear cell leukemia. It also found clear evidence of carcinogenic activity of 4-MeI in male and female mice based on increased evidence of alveolar/bronchiolar neoplasms.

In California, warning labels now need to be placed on products sold in the state that contain levels of 4-MeI above the “safe harbor” amount, Ms. Lawson said. The OEHHA has decided a daily intake of 4-MeI up to 29 micrograms a day over a lifetime is safe, she said.

The chemical 4-MeI is a byproduct formed — and not an ingredient added — during the heating and maillard browning process, Mr. Sethness said. Foods containing 4-MeI as a result of heating include coffee, some carbonated beverages, beer and wine, soy sauce, molasses and meats. He stressed 4-MeI is not banned in California.

Mr. Sethness said 4-MeI may appear in Class III (E150c) and Class IV (E150d) caramel colors. In Class IV colors, the reactants used help contribute to provide the brown color in colas and other dark foods and beverages. It requires a nitrogen (ammonia) source and sugar to make the chemical byproduct 4-MeI.
“Some of our customers have decided to switch to low 4-MeI caramel colors to meet specific California requirements,” Mr. Sethness said.

The company also manufactures Class I and Class II caramel colors that do not have 4-MeI, he said.
Last year the Center for Science in the Public Interest, Washington, petitioned the F.D.A. to prohibit Class III and Class IV caramel colors.

D.D. Williamson also is striving to meet customer requests.

“Even though we know that caramel colors are safe, we are working with our customers that wish to reduce the level of 4-MeI in their products,” Ms. Lawson said. “DDW offers multiple options: low 4-MeI versions of our Class III and Class IV caramel colors in both liquid and powder forms, as well as Class I options.”

She added, “Although DDW believes strongly that the developments in California are wholly unsupported by any scientific evidence or reasonableness, DDW scientists have formulated exclusive Class IV caramel colors with substantially reduced levels of 4-MeI for those food manufacturers struggling to avoid Prop-65 labels in California.”

The Coca-Cola Co., Atlanta, on March 9 said it was looking to reduce 4-MeI in its beverages.
“The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Co. is not changing the world famous formula for our Coca-Cola beverages,” the company said. “We have asked our caramel manufacturers to modify their production process to reduce the amount of 4-MeI in the caramel, but that will have no effect on the formula or on the great-tasting, high-quality products that consumers expect from us.”

The food industry still may be adjusting to a much-debated 2007 University of Southampton study in the United Kingdom that linked six colors to hyperactivity in children, but the situation is promising for companies that sell product in the United States. The U.S. Food and Drug Administration requires no warning labels for the colors, alternatives to the colors exist through natural sources, and the “Southampton six” applies to only three colors in the United States.

“The avoidance of Southampton colors is a big dilemma for international companies,” said Stefan Hake, chief executive officer of GNT USA, Inc., Tarrytown, N.Y. “For example, the same company may make colored cereals in the U.K. with fruits and vegetables, but the same branded cereal would contain FD&C colors in the United States.”

The F.D.A. in March 2011 concluded a causal relationship between exposure to color additives and hyperactivity in children in the general population has not been established. For certain susceptible children with attention deficit/hyperactivity disorder and other problem behaviors, however, the data suggest their condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, synthetic color additives.

In the United Kingdom, the Food Standards Agency has encouraged the food industry to participate in a voluntary ban of the six colors.

Three of the Southampton six — quinoline yellow (E104), carmoisine (E122) and ponceau 4R (E124) — are not permitted in the United States, said Carol Locey, product director, colors, for Kalsec, Inc., Kalamazoo, Mich. The other three colors involved in the Southampton study are sunset yellow FCF (E110), known as FD&C yellow No. 6 in the United States; allura red (E129), known as FD&C red No. 40 in the United States; and tartrazine (E102) is FD&C yellow No. 5.

“Typically, the color manufacturer and the consumer product producer will work hand in hand to develop a blend and dosage rate that will meet the required hue and intensity,” she said.

Lionel Lesegretain, business manager, NAT color, for Naturex, Avignon, France, said, “Orange hues can come from carotene, annatto or paprika. The compatibility and the stability of carotenoid emulsions in drinks are a technical challenge where we are innovating and bringing tailor-made solutions to the market.”

Ms. Locey said replacing red colors such as allura red, as well as carmoisine and ponceau 4R, may be difficult in high pH applications such as ice cream, milk and processed meat products with a kosher naturally-derived color.

“Fruit and vegetable concentrates such as grape, black carrot, radish, yam and cabbage work well in low pH environments such as acidic beverages and sauces,” she said. “However, in applications with a neutral to high pH, the pigments are more blue in hue and unstable.”
Mr. Lesegretain said fruit and vegetable concentrates providing red shades contain anthocyanins that are sensitive to pH.
“If pH is increasing, they become less and less stable in the finished product, and hues will vary from red in acidic conditions through to blue-gray in basic medium,” he said. “This makes them a perfect ingredient to be included in acidic applications like beverages and confectionery.”

GNT USA offers Exberry colors that are produced from fruit, vegetables and edible plants.

“All the (Southampton) colors listed can be replaced with fruit- and vegetable-based colors,” Mr. Hake said. “This just takes experience and understanding how different applications work and what the different processing conditions are so that the appropriate color can be applied.”

Food Ingredient Solutions, Teterboro, N.J., and Chr. Hansen, Horsholm, Denmark, also offer naturally-sourced colors. The Nielsen Co., on behalf of Chr. Hansen, conducted a survey of 5,000 consumers in 10 countries in 2011. The survey found 92% are concerned about artificial colors.

“Our research clearly shows that if you explain the difference between the coloring options, they will always choose the one that is fruit/vegetable based,” Mr. Hake said. “Consumers want to understand what they are eating, and as they become more educated, artificial colors will continue to be scrutinized.”

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